– Epclusa is the First Approved Pan-Genotypic Once Daily Single
Table Regimen for Chronic Hepatitis C Virus Infection in China –
FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Drug
Administration (CDA) has approved Epclusa® (sofosbuvir 400
mg/velpatasvir 100 mg) for the treatment of adults with genotype 1-6
chronic hepatitis C virus (HCV) infection. The CDA also approved Epclusa
in combination with ribavirin (RBV) for adults with HCV and
decompensated cirrhosis. Epclusa is the first pan-genotypic HCV single
tablet regimen (STR) approved in China.
The approval of Epclusa in China is supported by five international
Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4 and ASTRAL-5.
High overall rates of SVR12 (defined as undetectable HCV RNA 12 weeks
after completing therapy), ranging from 92-100 percent, were achieved
across difficult-to-cure patient populations including
treatment-experienced patients and those with compensated or
“The safety and efficacy profile of Epclusa are supported by large
clinical and real-world global datasets,” said Professor Lai Wei, Peking
University People’s Hospital and Institute of Hepatology, Peking
University. “With high cure rates across all HCV genotypes, Epclusa
could increase HCV treatment in China by potentially eliminating the
need for genotype testing, which can be a barrier to treatment in many
HCV is the fourth-most commonly reported infectious disease in China,
with approximately 10 million people infected. HCV genotypes 1, 2, 3 and
6 account for more than 96 percent of all cases.
In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 treatment-naïve
and treatment-experienced patients with genotype 1-6 HCV infection,
without cirrhosis or with compensated cirrhosis, received 12 weeks of
Epclusa. Ninety-eight percent (1,015/1,035) of patients achieved SVR12.
In the ASTRAL-5 study, 106 treatment-naïve and treatment-experienced
patients with genotype 1-6 HCV infection, without cirrhosis or with
compensated cirrhosis, who were coinfected with HIV and on a stable
antiretroviral therapy, received 12 weeks of Epclusa. Ninety-five
percent (101/106) of patients achieved SVR12.
The ASTRAL-4 study assessed the safety and efficacy of 12 weeks of
Epclusa with or without RBV or 24 weeks of Epclusa in 267 HCV-infected
patients with genotypes 1-4 and 6 decompensated cirrhosis (Child-Pugh
B). Patients with decompensated cirrhosis receiving Epclusa with RBV for
12 weeks achieved 94 percent (82/87) SVR12.
The most common adverse reactions (?10 percent) experienced by patients
treated with Epclusa in ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-5 were
headache and fatigue. The placebo-treated patients in the ASTRAL-1
experienced headache and fatigue at a similar frequency. The most common
adverse reactions (?10 percent) experienced by HCV-infected patients
with decompensated cirrhosis treated with Epclusa and RBV in ASTRAL-4
were fatigue, anemia, nausea, headache, diarrhea and insomnia. Four
patients treated with Epclusa with RBV, discontinued treatment due to
“As the first once-daily, interferon-free single tablet regimen for HCV
patients regardless of genotype, Epclusa offers physicians in China an
important new option for effectively treating their patients while
potentially helping to reduce the significant burden of HCV at a
population level,” said John F. Milligan, PhD, Gilead’s President and
Chief Executive Officer. “Gilead has now launched two direct-acting
antiviral treatments in China, and we are committed to supporting
efforts to screen and link patients to treatment, to help address the
country’s HCV epidemic.”
Epclusa received marketing approval from the U.S. Food and Drug
Administration (FDA) and the European Commission in 2016 as the first
pan-genotypic STR for HCV infection. It is also approved for use in 54
Sovaldi (sofosbuvir) as a single agent received marketing approval from
the China Food and Drug Administration in 2017 for the treatment of
adults infected with HCV genotype 1, 2, 3, 4, 5 or 6 and for adolescents
(aged 12 to 18 years) with HCV genotype 2 or 3, as a component of a
combination antiviral treatment regimen.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR
EPCLUSA IN U.S.
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV
Test all patients for evidence of current or prior hepatitis B virus
(HBV) infection before initiating treatment with EPCLUSA. HBV
reactivation has been reported in HCV/HBV coinfected patients who were
undergoing or had completed treatment with HCV direct acting antivirals
(DAAs) and were not receiving HBV antiviral therapy. Some cases have
resulted in fulminant hepatitis, hepatic failure, and death. Cases have
been reported in patients who are HBsAg positive, in patients with
serologic evidence of resolved HBV, and also in patients receiving
certain immunosuppressant or chemotherapeutic agents; the risk of HBV
reactivation associated with treatment with HCV DAAs may be increased in
patients taking these other agents. Monitor HCV/HBV coinfected patients
for hepatitis flare or HBV reactivation during HCV treatment and
post-treatment follow-up. Initiate appropriate patient management for
HBV infection as clinically indicated.
If EPCLUSA is used in combination with ribavirin (RBV), all
contraindications, warnings and precautions, in particular pregnancy
avoidance, and adverse reactions to RBV also apply. Refer to RBV
Warnings and Precautions
Serious Symptomatic Bradycardia When Coadministered with Amiodarone:
Amiodarone is not recommended for use with EPCLUSA due to the risk of
symptomatic bradycardia, particularly in patients also taking beta
blockers or with underlying cardiac comorbidities and/or with advanced
liver disease. A fatal cardiac arrest was reported in a patient taking
amiodarone who was coadministered a sofosbuvir containing regimen. In
patients without alternative, viable treatment options, cardiac
monitoring is recommended. Patients should seek immediate medical
evaluation if they develop signs or symptoms of bradycardia.
Risk of Reduced Therapeutic Effect Due to Concomitant Use of EPCLUSA
with P-gp Inducers and/or Moderate to Potent Inducers of CYP2B6, CYP2C8
or CYP3A4: Rifampin, St. John’s wort, and carbamazepine are not
recommended for use with EPCLUSA as they may significantly decrease
sofosbuvir and/or velpatasvir plasma concentrations.
The most common adverse reactions (?10%, all grades) with EPCLUSA were
headache and fatigue; and when used with RBV in decompensated cirrhosis
were fatigue, anemia, nausea, headache, insomnia, and diarrhea.
Coadministration of EPCLUSA is not recommended with topotecan due to
increased concentrations of topotecan.
Coadministration of EPCLUSA is not recommended with proton-pump
inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin,
rifapentine, efavirenz, and tipranavir/ritonavir due to decreased
concentrations of sofosbuvir and/or velpatasvir.
Consult the full Prescribing Information for EPCLUSA for more
information on potentially significant drug interactions, including
EPCLUSA is indicated for the treatment of adults with chronic hepatitis
C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis
or with compensated cirrhosis and in combination with ribavirin for
those with decompensated cirrhosis.
About Gilead Sciences, Inc.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that
discovers, develops and commercializes innovative medicines in areas of
unmet medical need. The company strives to transform and simplify care
for people with life-threatening illnesses around the world. Gilead has
operations in more than 35 countries worldwide, with headquarters in
Foster City, California.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that physicians may not see the benefits of prescribing Epclusa. These
risks, uncertainties and other factors could cause actual results to
differ materially from those referred to in the forward-looking
statements. The reader is cautioned not to rely on these forward-looking
statements. These and other risks are described in detail in Gilead’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as
filed with the U.S. Securities and Exchange Commission. All
forward-looking statements are based on information currently available
to Gilead, and Gilead assumes no obligation to update any such
U.S. Full Prescribing Information for Epclusa and Sovaldi, including BOXED
WARNING is available at www.gilead.com
Epclusa and Sovaldi are registered trademarks of Gilead Sciences,
Inc., or its related companies.
For more information on Gilead Sciences, please visit the company’s
website at www.gilead.com,
follow Gilead on Twitter (@GileadSciences)
or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792 (Investors)
Choi, 650-425-5483 (Media)
Source: Gilead Sciences, Inc.